Plate selection user interface and design tool with database

ABSTRACT

Described herein are systems and methods in which a surgeon can use computer-implemented deformity assessment and correction tools to create 3D models of a bone. To ensure adequate healing, a surgeon may choose to use a prefabricated bone plate, a semi-customized bone plate, or a fully-customized bone plate to hold first and second bone portions in a corrected position. To select the appropriate prefabricated bone plate, the surgeon may identify three landmark locations on the first and second bone portions corresponding to desired fixation hole locations on the bone plate. The surgeon can then use a software application to evaluate multiple bone plate designs in a library and compare the average proximity of the landmark locations to fixation hole locations on each of the bone plate designs. Then, the surgeon can determine which bone plate design best fits the patient anatomy based on his comparison.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing date of U.S.Provisional Patent Application No. 62/482,422 filed Apr. 6, 2017, thedisclosure of which is hereby incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to orthopedic surgeriesinvolving bone plating systems and methods of bone plate fixation.Particularly, disclosed herein is a patient-specific plating system thatmay include a best-fit bone plate, a semi-customized bone plate, or afully-customized bone plate, in addition to methods of creating andusing said bone plates.

BACKGROUND OF THE INVENTION

Bone plating systems are often used to correct bone deformitiesresulting from trauma or degenerative conditions. For example, surgeonsuse bone plating systems to set or stabilize bone portions in casesinvolving fractures, osteotomies, or other deformity conditions.

In many applications, a bone plate is used to hold one or more boneportions in a corrected position for healing. Some surgeons may chooseto use a standard bone plate that could sufficiently hold the one ormore bone portions in the corrected position for healing, for example,within a predefined confidence interval. Use of a standard bone platecan shorten the duration and difficulty of the correction procedure. Astandard bone plate also may be cheaper and easier to manufacture,compared to a semi- or fully-customized bone plate. Because of theseadvantages, there is a need for a simple method of selecting a standardbone plate that best fits a patient's bone anatomy. However, a boneplate of standard size and shape may be undesirable for a few reasons.

As one example, a standard bone plate may not fit special situations orcomplex anatomy. This is especially relevant for patients with Charcot,midfoot, and ankle deformities.

Also, a standard bone plate may cause pain and discomfort for a patient.This may occur when a bone-contacting surface of a standard bone platedoes not correspond well with a patient's bone anatomy.

Further, a standard bone plate may negatively impact the healingprocess. In some cases, the location and number of screw holes on thestandard bone plate is not sufficient for proper plate fixation. Forexample, if the location of a screw hole corresponds to a weak bone areain a patient with osteoporosis, then the bone plate may not be properlysecured and the one or more bone portions may not be properly aligned.

Thus, there remains a need for bone plating systems that can be semi- orfully-customized for specific patients in order to treat specialsituations or complex anatomy, reduce pain and discomfort, and/orpromote the healing process.

Additionally, in certain cases, a surgeon may need to make a bone cut inorder to arrange the one or more bone portions in the corrected positionfor healing. Often, a surgeon may need to perform bone cuts at multipleangles, which can be difficult for special situations or complexanatomy. Therefore, it would be desirable for a bone plating system toinclude a complementary cut guide to direct bone cuts which may berequired to properly position the one or more bone portions in thecorrected position.

SUMMARY OF THE INVENTION

A first aspect of the present invention is a bone plate for correcting adeformity in first and second bone portions having a deformed positionwith respect to each other. The bone plate may include a body havingfirst and second sections and superior and inferior surfaces, whereinthe inferior surface having a preoperatively planned shape to match anouter surface of each of the first and second bone portions when thefirst and second bone portions are in a corrected position differentthan the deformed position, and wherein the inferior surface of thefirst section is adapted to contact the outer surface of the first boneportion above an apex point of the deformity and the inferior surface ofthe second section is adapted to contact the outer surface of the secondbone portion below the apex point of the deformity when the first andsecond bone portions are in the corrected position.

In accordance with other embodiments of the first aspect, the body maydefine a profile wherein the profile is preoperatively planned to matchthe outer surfaces of the first and second bone portions in thecorrected position. Moreover, a thickness of the body may define alinear distance between the superior and inferior surfaces. In someembodiments, the thickness may vary from a first end adjacent the firstsection to a second end adjacent the second section.

In certain applications, the bone plate may also include at least onefixation hole in each of the first and second sections of the body andthe location of the fixation holes may correspond to areas of the firstand second bone portions having higher relative density. Accordingly, insome embodiments, the bone plate may further comprise a first fixationelement insertable into the first fixation hole in the first section anda second fixation element insertable into the second fixation hole inthe second section. Further, the fixation hole may be adapted to receivea fixation element at a plurality of angles. For example, in someembodiments, one of the fixation holes may be larger than another one ofthe fixation holes such that a fixation element in the one fixation holeis able to change angles during insertion. Also, the first and secondfixation elements may be different lengths.

A second aspect of the present invention is also a bone plate forcorrecting a deformity in first and second bone portions having adeformed position with respect to each other. In the second aspect, thebone plate may include a body having first and second sections andsuperior and inferior surfaces, the inferior surface having apreoperatively planned shape to match an outer surface of each of thefirst and second bone portions when the first and second bone portionsare in a corrected position different than the deformed position, thebody also having at least one fixation hole adapted to contact an areaof the first or second bone portions having higher relative density.

A third aspect of the present invention is a system for correcting adeformity in first and second bone portions having a deformed positionwith respect to each other. The system may include a cut guide fixableto each of the first and second bone portions in a deformed position,the cut guide having at least one cutting slot for resecting a bone cutout from at least one of the first and second bone portions. The systemmay also include a bone plate having first and second sections andsuperior and inferior surfaces, the inferior surface having apreoperatively planned shape to match an outer surface of each of thefirst and second bone portions when the first and second bone portionsare in a corrected position different than the deformed position. Thesystem may further include at least two fixation elements for fixing thebone plate to the first and second bone portions in the correctedposition.

A fourth aspect of the present invention is a method for generating acorrected bone model. The method may include calculating an apex pointof a deformity in first and second bone portions, the first and secondbone portions having a deformed position with respect to each other;defining an axis of rotation about the apex point; and rotating thesecond bone portion along the axis of rotation until the first andsecond bone portions are in a corrected position different from thedeformed position.

In accordance with other embodiments of the fourth aspect, the methodmay also include defining an osteotomy plane based on an apex point. Themethod may further include calculating the area of a gap between thefirst and second bone portions in the corrected position.

A fifth aspect of the present invention is a method for designing a boneplate for correcting a deformity in first and second bone portionshaving a deformed position with respect to each other. The method mayinclude evaluating relative bone densities of the first and second boneportions; defining a profile of a body of the bone plate according to acorrected bone model, wherein first and second bone portions are in acorrected position different from the deformed position; defining aninferior surface of the body of the bone plate according to thecorrected bone model; and defining a location of at least one fixationhole in the body of the bone plate based on the evaluation of relativebone densities, wherein the location of the at least one fixation holecorresponds to an area having higher relative density.

In accordance with other embodiments of the fifth aspect, the method mayalso include determining the total number of fixation holes in the bodyof the bone plate based on the evaluation of relative bone densities.The method may further include varying a thickness of the body of thebone plate from a first end adjacent a first section of the bone plateto a second end adjacent a section of the bone plate according to thecorrected bone model, wherein the thickness of the body is defined by alinear distance between superior and inferior surfaces of the body. Insome embodiments, the step of defining a profile of the body of the boneplate includes customizing the profile to match an outer surface of eachof the first and second bone portions in the corrected position. Inother embodiments, the step of defining a location of at least onefixation hole includes enforcing boundaries corresponding to minimum andmaximum plate dimensions.

In certain applications, the method may additionally include generatinga cut guide to direct bone cut outs or generating a drill guide todirect insertion of fixation elements at a pre-specified drill holeangle. In some embodiments, the step of generating a drill guideincludes calculating a desired length of a fixation element.

Also, in certain applications, the step of evaluating relative bonedensities is based on comparative analysis between scan slices of a bonesample and scan slices of the first and second bone portions. In certainother embodiments, the step of evaluating relative bone densities isbased on comparative analysis between scan slices of the first andsecond bone portions.

Moreover, in some embodiments of the method, it may also includedetermining the size of at least one fixation hole according to thecorrected bone model such that a fixation element can pivot duringactuation.

A sixth aspect of the present invention is a method for correcting adeformity in first and second bone portions having a deformed positionwith respect to each other. The method may include calculating an apexpoint of the deformity; positioning a bone plate having first and secondsections and superior and inferior surfaces, the inferior surface havinga preoperatively planned shape to match an outer surface of each of thefirst and second bone portions when the first and second bone portionsare in a corrected position different than the deformed position;securing the first section of the bone plate to the first bone portionwith a first fixation element; and rotating the second bone portionabout the apex point until the bone is in the corrected position.

In accordance with other embodiments of the sixth aspect, the method mayalso include securing the second section of the bone plate to the secondbone portion with a second fixation element. Moreover, in someembodiments, an inferior surface of the first section is adapted tocontact the outer surface of the first bone portion above an apex pointof the deformity and an inferior surface of the second section isadapted to contact the outer surface of the second bone portion belowthe apex point of the deformity when the first and second bone portionsare in the corrected position.

In certain applications, the rotating step of the method includesinserting a second fixation element through a fixation hole in thesecond section of the bone plate and into at least a part of the secondbone portion; and actuating the second fixation element. The method mayalso include placing a bone graft in a gap between the first and secondbone portions in the corrected position. Furthermore, the method mayinclude using a cut guide to direct bone cut outs or using a drill guideto direct insertion of fixation elements at a pre-specified drill holeangle. Even further, the method may also include performing an osteotomyat the apex point of the deformity.

A seventh aspect of the present invention is a cut guide for directing acut in a bone. The cut guide may include a body having superior andinferior surfaces and upper and lower sections, the inferior surfacehaving a preoperatively planned shape to match an outer surface of thebone, the body also having at least one cutting slot extending from thesuperior surface through to the inferior surface, wherein the bone hasproximal and distal surfaces and two opposing medial sides, and whereinthe upper section of the body is adapted to contact the proximal surfaceof the bone and the lower section of the body is adapted to contact amedial side of the bone.

In accordance with other embodiments of the seventh aspect, the cutguide may also include at least one pin, wherein the body includes atleast one aperture adapted to receive the at least one pin. In someembodiments, the at least one cutting slot of the cut guide correspondsto a closing wedge osteotomy. In some other embodiments, the at leastone cutting slot corresponds to an opening wedge osteotomy.

An eighth aspect of the present invention is a method for selecting abone plate for correcting a deformity in first and second bone portionshaving a deformed position with respect to each other. The method mayinclude identifying a landmark location on a corrected bone model,wherein first and second bone portions are in a corrected positiondifferent from the deformed position. It may also include accessing alibrary of prefabricated bone plate designs and comparing a landmarklocation to a fixation hole location on each of the prefabricated boneplate designs in the library. The method may further include determiningwhich prefabricated bone plate design best fits the corrected bone modelbased on an average proximity of the landmark location and the fixationhole location.

In some embodiments, the landmark locations may correspond to areas ofthe first and second bone portions having higher relative densities.Moreover, there may be at least landmark locations wherein two areextreme proximal locations and one is an extreme distal location.

In accordance with other embodiments of the eighth aspect, the comparingstep may involve showing the landmark locations and at least one clusterof possible fixation hole locations on the corrected bone model,corresponding to possible prefabricated bone plate designs. In certainapplications, the method may also include selecting an additionallandmark location based on the at least one cluster of possible fixationhole locations. The method may also include changing the location of alandmark and regenerating the at least one cluster of possible fixationhole locations.

Furthermore, in some embodiments of the eighth aspect, the averageproximity must be within a predefined tolerance level that would beadequate for healing. Also, the determining step may further involveevaluating the adequacy of the best fit prefabricated bone plate designfor healing.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention can now be discussed withreference to the appended drawings. It is appreciated that thesedrawings depict only typical embodiments of the invention and aretherefore not to be considered limiting of its scope.

FIG. 1 is a perspective view of a patient-specific plating systemaccording to one embodiment.

FIG. 2 is a block diagram depicting a pre-operative plan according toone embodiment.

FIG. 3 shows one embodiment of initiating a case request, as part of thepre-operative plan of FIG. 2.

FIG. 4 shows one embodiment of assessing a deformity, as part of thepre-operative plan of FIG. 2.

FIG. 5 shows one embodiment of correcting a deformity, as part of thepre-operative plan of FIG. 2.

FIG. 6 shows one embodiment of an osteotomy to correct the deformity ofFIG. 5.

FIG. 7 shows an osteotomy plane according to the osteotomy of FIG. 6.

FIGS. 8a and 8b show one embodiment of a cut guide according to theosteotomy of FIG. 6.

FIG. 9 shows another embodiment of a cut guide according to theosteotomy of FIG. 6.

FIG. 10 shows a perspective view of the cut guide of FIG. 9.

FIG. 11 shows one embodiment of a cut guide according to an osteotomy tocorrect a different deformity.

FIG. 12 shows one embodiment of evaluating bone density, as part of thepre-operative plan of FIG. 2

FIG. 13 shows one embodiment of projecting a plate profile over acorrected bone model, as part of the pre-operative plan of FIG. 2

FIG. 14 shows one embodiment of visualizing a screw trajectory through acorrected bone model, as part of the pre-operative plan of FIG. 2

FIG. 15 shows a method to define minimum and maximum plate dimensions,as part of the pre-operative plan of FIG. 2

FIG. 16 shows boundaries calculated according to the method of FIG. 15.

FIG. 17a shows one embodiment of a plate profile with minimum andmaximum plate dimensions calculated according to the method of FIG. 15.

FIG. 17b shows an enlarged view of the plate profile of FIG. 17 a.

FIG. 18 shows minimum plate dimensions calculated according to themethod of FIG. 15.

FIG. 19 shows maximum plate dimensions calculated according to themethod of FIG. 15.

FIG. 20 shows one embodiment of a contoured plate with manipulated platesurfaces.

FIG. 21 shows one embodiment of a drill guide.

FIG. 22 shows one embodiment of visualizing an osteotomy, as part of thepre-operative plan of FIG. 2

FIG. 23 shows one embodiment of visualizing a patient-specific platingsystem on a corrected bone model, as part of the pre-operative plan ofFIG. 2

FIG. 24 shows one embodiment of visualizing a bone graft, as part of thepre-operative plan of FIG. 2

FIG. 25 shows a perspective view of yet another embodiment of a cutguide having first and second guide components coupled together via ajoint mechanism.

FIG. 26 shows a partially exploded view of the cut guide of FIG. 25.

FIG. 27 shows another perspective view of the cut guide of FIG. 25 witha front plane view of the joint mechanism.

FIG. 28 shows another embodiment of a joint mechanism that can be usedto couple first and second guide components.

FIG. 29 shows another method to define minimum and maximum platedimensions, as part of the pre-operative plan of FIG. 2.

FIG. 30 shows tolerance ranges calculated according to the method ofFIG. 29.

FIG. 31 shows yet another method to define minimum and maximum platedimensions, as part of the pre-operative plan of FIG. 2.

FIG. 32 is a block diagram depicting a pre-operative plan according to asecond embodiment.

FIG. 33 shows one embodiment of generating a corrected bone model, aspart of the pre-operative plan of FIG. 32.

FIG. 34 shows one embodiment of identifying landmarks, as part of thepre-operative plan of FIG. 32.

FIG. 35 shows one embodiment of determining a best-fit design, as partof the pre-operative plan of FIG. 32.

FIG. 36 shows one embodiment of viewing a cluster of possible fixationhole locations, as part of the pre-operative plan of FIG. 32.

FIG. 37 shows another embodiment of viewing a cluster of possiblefixation hole locations, as part of the pre-operative plan of FIG. 32.

FIGS. 38-40 show different embodiments of cut guides having differentcutting slot designs.

DETAILED DESCRIPTION OF THE INVENTION

Those of skill in the art can recognize that the following descriptionis merely illustrative of the principles of the invention, which may beapplied in various ways to provide many different alternativeembodiments.

Depending on the application, a surgeon may choose to use a customizedbone plate or a prefabricated bone plate.

The following paragraphs will describe the creation and use of afully-customized patient specific bone plate. A fully-customized boneplate may provide better deformity correction, for example, whentreating special situations or complex anatomy. A fully-customized boneplate having a preoperatively planned shape to match the outer surfaceof the patient's bone anatomy may also reduce pain and discomfort and/orpromote the healing process. It also can help the surgeon ensure properplate alignment and fixation during the surgery.

FIG. 1 shows a patient-specific plating system 10 according to oneembodiment of the present invention. System 10 includes a customizedbone plate 20 comprising a body 23 having a first section 21 and asecond section 22. Body 23 also includes a superior surface 27 and aninferior surface 29 (not shown). Inferior surface 29 is abone-contacting surface. As shown, body 23 further includes fixationholes 30 adapted to receive fixation elements 60.

The creation and use of a customized bone plate according to the presentinvention can involve in-depth pre-operative planning One embodiment ofa pre-operative plan 80 is illustrated as a flowchart in FIG. 2.

Many steps of pre-operative plan 80 use a software application. Thesoftware application runs as an interactive platform in which a surgeoncan design and customize a bone plate for a specific patient. Thesoftware application could be web-based or installed by CD.

Computer-implemented methods of generating a data set that geometricallydefines a bone plate design are known in the art. For example, U.S. Pat.Pub. No. 2015/0051876, hereby incorporated by reference in its entirety,discloses a technique for generating such a bone plate design.

The first step of pre-operative plan 80 may comprise logging-in to thesoftware application and initiating a case request 100 (FIG. 2). In thepreferred embodiment, each surgeon has a unique username and password toreach a profile page. The surgeon's profile page may have a list ofpatients and associated cases. At this point, the surgeon may optionallymodify an existing case or request to initiate a new case.

Upon initiating a new case for a patient, the surgeon can enter casedetails, e.g., patient information 110, hospital information 120, andsurgeon information 130, as shown in FIG. 3. The surgeon can also entertreatment information 140 including: anatomy 141; indication 142, e.g.,Charcot, midfoot, ankle, etc.; and deformity 143, e.g., assessmentrequired, multiple assessments required, correction required, etc. Inaddition, the surgeon can select an expected delivery date 145 and enterany other design notes 146. For example, the surgeon may note, “provideadditional fixation hole at 2^(nd) metatarsal” based on a desiredposition for healing and/or experience from other similar cases.Moreover, the surgeon may indicate a need for a cut guide 421, a bonegraft 441, and/or a drill guide 621, as will be discussed below.

As the next step of pre-operative plan 80, the surgeon can upload a scanof the patient's bone into the software application to create a deformedbone model 200 (FIG. 2). In the deformed bone model, there is a firstportion of bone 11 and a second portion of bone 12 which are in adeformed position with respect to each other.

In the preferred embodiment, a computed tomography (“CT”) image ormagnetic resonance imaging (“MRI”) image including 3D data may be usedsuch that the deformed bone model can closely mirror the patient'sanatomy. Instead, an X-ray image including 2D data could also be used.

As another step of pre-operative plan 80, the surgeon may use a‘Deformity Assessment Tool’ to calculate an apex point 310 of adeformity, also known as the ACA-CORA to those skilled in the art 300(FIG. 2). That is, the ‘Deformity Assessment Tool’ may be used tocalculate an axis of correction of angulation (“ACA”) and a center ofrotation of angulation (“CORA”) according to the deformed bone model(FIG. 4). The surgeon may use standard measurement techniques known tothose of ordinary skill in the art to calculate apex point 310. Forexample, Principles of Deformity Correction, by Dror Paley, published in2002 and hereby incorporated by reference in its entirety, disclosesmany such techniques.

After calculating apex point 310 of the deformity, the surgeon may use a‘Deformity Correction Tool’ to generate a corrected bone model 400 (FIG.2). In the corrected bone model, first and second bone portions 11, 12are in a corrected position different from the deformed position. As anexample, the software application may be used to calculate a Meary'sangle of a deformity and simulate a correction procedure in order togenerate a corrected bone model for Charcot or Midfoot indications.

To generate the corrected bone model, the surgeon can project an axis ofrotation R about apex point 310 onto the deformed bone model. Then, thesurgeon can visualize deformation correction in real time by draggingand rotating the second bone portion 12 along the axis of rotation R fora certain distance Θ, as will be discussed further below (FIG. 5).

In certain cases, the surgeon may need to perform an osteotomy in orderto correct the deformity. Two common types of osteotomy procedures maybe used, i.e., a closing wedge or an opening wedge. A closing wedge mayrequire an inverted “V” cut, e.g., for acute planar correction, or acomplex double “V” cut, e.g., for acute two degree correction. A complexdouble “V” cut may also be known as a “trapezoid” cut to those havingordinary skill in the art. FIG. 6 shows an osteotomy plane Ocorresponding to a closing wedge osteotomy. An opening wedge generallyrequires a straight “V” cut, e.g., for acute rotational correction.

To visualize the osteotomy, the surgeon may project the osteotomy planeO onto the deformed model, as shown in FIG. 7. In the preferredembodiment, the osteotomy plane O passes through apex point 310.Osteotomy plane O may define a bone cut out 802 that is to be removed,as will be discussed further below. Notably, the surgeon can manipulateosteotomy plane O in the anterior, posterior, lateral, medial, and axialdirections as desired. The surgeon can also view the osteotomy plane Oin a 2D or 3D plane.

In some cases, the surgeon may require a cut guide for an osteotomyprocedure. FIG. 8 shows cut guide 422 for acute planar correction, whichcorresponds to the closing wedge osteotomy in FIG. 6. Cut guide 422identifies bone cut out 802 required for proper alignment of first andsecond bone portions 11, 12 and for proper plate placement (FIG. 8b ).When the surgeon is entering treatment information 100, the surgeon hasthe option to indicate a need for a cut guide 421 (FIG. 3). Thus, thesoftware application can create a complementary cut guide according tothe corrected bone model 420 (FIG. 2).

The surgeon may additionally modify the dimensions of the cut guide inreal time using the software application. For example, the surgeon maydesign the cut guide to include another aperture adapted to receive aguiding pin and/or a fixation hole adapted to receive a fixationelement. FIG. 38 shows a cut guide 3800 having a fixation hole 3810. Thecutting slots 3827 of cut guide 3800 extend up to the axis of rotation.FIG. 39 shows a cut guide 3900 having a fixation hole 3910; however, thecutting slots 3927 are distinct in this “trimmed” embodiment. Thesurgeon may also design the cut guide depending on the blade type. FIG.40 shows a cut guide 4000 having a fixation hole 4010. The cutting slots4027 are open-ended and adapted to receive all blade types.

In the embodiment of FIGS. 8a and 8b , cut guide 422 has superior andinferior surfaces 423,425. Inferior surface 425 may be preoperativelyplanned to match the patient's bone anatomy in order to help ensureproper placement of cut guide 422. In turn, this may also help a surgeonperform more accurate bone cuts.

As shown in FIGS. 8a and 8b , cut guide 422 also has two angled cuttingslots 427 for making a wedge shaped resection, the cutting slots 427sized to receive an oscillating saw blade or similar cutting tool. Inthe preferred embodiment, slots 427 do not allow the saw blade tosubstantially vibrate during the resection procedure. Cut guide 422 mayalso have an aperture 428 adapted to receive a pin 429. Pin 429 may helpproperly position the plate during the resection procedure. In someembodiments, cut guide 422 may also include a fixation hole 1428 adaptedto receive a fixation element 1429 in order to help maintain theposition of cut guide 422 during the resection procedure.

After the resection procedure, the surgeon may desire to performadditional free-hand bone cuts in order to arrange the first and secondbone portions 11, 12 in the corrected position. Thus, cut guide 422 maybe used to perform a straight cut, closing wedge osteotomy.

FIG. 9 shows an alternative embodiment of a cut guide 432 correspondingto the closing wedge osteotomy in FIG. 6. Cut guide 432 has many similarfeatures that are similarly numbered in comparison with cut guide 422.As such, cut guide 432 has superior and inferior surfaces 433,435 whereinferior surface 435 may also be preoperatively planned to match thepatient's bone anatomy. Cut guide 432 also has slots 437 adapted toreceive a cutting tool. Further, cut guide 432 includes aperture 438adapted to receive pin 439 and fixation hole 1438 adapted to receivefixation element 1439.

In certain cases, the surgeon may need to perform multiple bone cuts atmultiple angles which can be difficult to perform free hand. Tofacilitate the resection procedure, cute guide 432 may include upper andlower portions 434,436. Then, in order to perform accurate multi-anglecuts, the upper portion 434 of cut guide 432 may contact a proximalsurface 1000 of a bone, opposite a distal surface 2000; while the lowerportion 436 of cut guide 432 may contact one of two opposing medialsides 3000 of the bone. Thus, the surgeon can make multiple multi-anglecuts using a single cut guide. This may be especially useful in caseswhere a complex double “V” cut is required.

FIG. 25 shows another embodiment of a cut guide 3422 corresponding tothe closing wedge osteotomy in FIG. 6. Cut guide 3422 has many similarfeatures that are similarly numbered in comparison with cut guides 422,432. Cut guide 3422 has superior and inferior surface 3423, 3425 whereinferior surface 3425 may be preoperatively planned to match thepatient's bone anatomy. Cut guide 3422 also has slots 3427 adapted toreceive a cutting tool as well as apertures 3428 adapted to receive pins4329 (not shown). Cut guide 3422 may additionally have fixation holesadapted to receive fixation elements as discussed above in relation todifferent embodiments.

Cut guide 3422 includes a posterior section 3431 and an anterior section3432 adapted to contact first and second bone portions 11, 12respectively. Posterior section 3431 and anterior section 3432 may alsobe referred to as first and second cut guide components, respectively.As shown more clearly in FIG. 26, the posterior and anterior sections3431, 3432 are connected by a joint mechanism, i.e. gear module 3500.Each posterior, anterior section 3431, 3432 includes a verticalprojection 3450 with at least one peg hole 3452. The distance betweenpeg holes 3452 on posterior and anterior sections 3431, 3432 may bedefined by distance A.

Gear module 3500 includes posterior and anterior sections 3511, 3512which may be aligned with the posterior and anterior sections 3431, 3432of cut guide 3422. Each section 3511,3512 of gear module 3500 mayfurther include at least one peg 3552 insertable into the at least onepeg hole 3452 in sections 3431,3432 of cut guide 3422. The distancebetween the pegs 3552 may be defined by distance B. As such, distances Aand B should be equal such that pegs 3552 are insertable into peg holes3452.

Gear module 3500 may be used after the surgeon makes the desired bonecuts in order to manipulate or rearrange the first and second boneportions 11, 12 from a deformed position into a corrected position. Gearmodule 3500 may be designed such that anterior section 3512 has anoperable end such as a hinged gear head 3522, while posterior section3511 includes an actuator 3521 configured to operate the hinged gearhead 3522. That is, upon actuation of actuator 3521, hinged gear head3522 will rotate about an axis G causing the distances A,B to decreaseand forcing the posterior and anterior sections 3431,3432 of cut guide3422 closer together such that first and second bone portions 11,12 maybe arranged in the corrected position.

FIG. 27 shows an axis of rotation G corresponding to the center of thehinged gear head 3522. When the software application designs cut guide3422, the position of axis G and the location of pegs 3552 andcorresponding peg holes 3452 can be calculated according to thecorrected bone model. That is, the software application will align theaxis of rotation R and axis G. Accordingly, actuation of the hinged gearhead 3522 may cause the anterior section 3512 of gear module 3500 torotate about axis G and force the anterior section 3432 of cut guide3422 to move toward the posterior section 3431. As such, actuation ofthe hinged gear head 3522 may pull the first and second bone portions11, 12 from the deformed position into the corrected position. Indifferent cases, different embodiments of cut guide 3422 may includemore than two pegs 3522 and peg holes 3452. Moreover, the position ofaxis G and distances A, B may also be different.

It may be useful for a surgeon to use gear module 3500 to restrictmotion of the first and second bone portions 11, 12 after the resectionprocedure has been performed. The hinged design of gear head 3522 canhelp the doctor ensure the rotation motion is about axis G such that thefirst and second bone portions 11, 12 may be aligned in the correctedposition.

FIG. 28 shows another embodiment of a joint mechanism, i.e. hingedmodule 3600, that may connect posterior and anterior sections 3431, 3432of cut guide 3422. As described above, hinged module 3600 may also beused to rearrange the first and second bone portions 11, 12 from thedeformed position into the corrected position. Like gear module 3500,the hinged module 3600 similarly has posterior and anterior sections3611, 3612 and pegs 3652 insertable into peg holes 3452. Further, an endof the anterior section 3612 may fit within an end of the posteriorsection 3611 and a pin 3621 may be inserted through both sections 3611,3612 along an axis of rotation J in order to form a hinged joint. Thesoftware application may again be used to calculate the axis J andlocation of pegs 3652 and corresponding peg holes 3452 according to thecorrected bone model. That is, the software application will align theaxis of rotation R and axis J. As such, the surgeon may manipulate theanterior section 3611 of module 3600 by hand to rotate the anteriorsection 3432 of the cut guide toward the posterior section 3431 aboutaxis J. Thus, the surgeon may manually arrange the first and second boneportions 11, 12 in the corrected position.

In an alternative embodiment of hinged module 3600, a ball-joint modulemay be used. Like the other joint mechanisms 3500, 3600, the ball-jointmodule may have pre-operatively planned posterior and anterior sectionswith pegs insertable into peg holes 3452. Moreover, an end of theanterior section may be a sphere that fits within a cavity in an end ofthe posterior section, thereby forming a ball-joint. Insertion of thepegs into peg holes 3452 will restrict polyaxial motion of theball-joint such that the anterior section of the ball-joint module canonly rotate along a single ball-joint axis. The software will design thelocation of pegs and corresponding peg holes 3452 according to thecorrected bone model, such that the ball-joint axis is aligned with theaxis of rotation R. Accordingly, the surgeon may manipulate the anteriorsection of the ball-joint module by hand to arrange the first and secondbone portions 11, 12 in the corrected position.

As an alternative to the closing wedge osteotomy of FIG. 6, a cut guide1422 as shown in FIG. 11 may be used to perform an opening wedgeosteotomy for certain other cases. Cut guide 1422 has many similarfeatures that are similarly numbered in comparison with cut guides422,432. Accordingly, cut guide 1422 has superior and inferior surfaces1423, 1425; slots 1427; and aperture 1428 adapted to receive pin 1429(not shown). Additionally, cut guide 1422 has at least one fixation hole2428 adapted to receive fixation element 2429 (not shown).

Cut guide 1422 may optionally be designed to include posterior andanterior sections like cut guide 3422, as well as a hinged modulesimilar to gear module 3500 or ball-joint module 3600 that would forcethe posterior and anterior sections of the cut guide closer together inorder to arrange the first and second bone portions 11, 12 in thecorrected position.

Often, the corrected bone model may show a gap 803 between first andsecond bone portions 11, 12. In some cases, it is desirable to leave gap803 to allow for bone regrowth. In other cases, the surgeon may requirea bone graft 442 to fill gap 803 (FIG. 23). When the surgeon is enteringtreatment information 100, the surgeon has the option to indicate a needfor a bone graft 441 (FIG. 3). Thus, the software application cancalculate the area of a bone graft according to the corrected bone model440 (FIG. 2). The software application can also provide recommendationsfor ordering bone substitutes. For example, allograft material,polyetheretherketone, stainless steel, or titanium could be used.

In some embodiments, a surgeon may use scan data from a patient'scontralateral bone across the sagittal plane to generate the correctedbone model. In those cases, the surgeon may not need to create adeformed bone model 200 or use the Deformity Assessment Tool 300,350(FIG. 2). Still, the surgeon can design a patient-specific platingsystem.

In other embodiments, it is possible for a surgeon to use scan data froma database with a library of patient scans for creating the correctedbone model. The database may further include a library of correspondingbone plate designs for the patient scans. Those bone plate designs maybe used as a template and further customized for a patient-specificplating system.

In certain cases, a generic corrected bone model may be configured tofit what may be referred to as a 5% female and a 95% male such that itmay be used for almost any patient. These generic models may also begender-specific or age-specific.

As yet another step of pre-operative plan 80, the surgeon may evaluatebone density. As one option, this can be done by performing comparativeanalysis between scan slices of a bone sample and the same bone in thepatient 500 (FIG. 2). The scan of the bone sample may be obtained from adatabase with a library of patient scans.

Using the software application, the surgeon may perform segmentationanalysis on a scan of the bone sample and a scan of the patient's boneto create scan slices. For example, the scan slice may have a thicknessof 1 mm similar to X-ray images, but with more detail. Then, thesoftware application can use an algorithm to compare the scan slices ofthe bone sample with the scan slices of the patient's bone.

The same algorithm may be used to distinguish and segregate each scanslice of the patient's bone with higher density, about the same density,or lower density as compared to the scan slice of the bone sample. Eachof the scan slices of the patient's bone may be assigned a color on theRGB color scale to indicate areas of relatively high, moderate, or lowdensity compared to the bone sample. After, the colored scan slices maybe combined to show bone volume. The 3D color scheme may then be appliedto the corrected bone model and create a color map for the surgeon toevaluate bone density.

Thus, the software application can provide the surgeon with visualinformation to evaluate bone density. As FIG. 12 shows, the surgeon canvisualize the relative bone densities, where dark grey represents arelatively high density bone area (510), grey represents a relativelymoderate density bone area (520), and light grey represents a relativelylow density bone area (530). It is possible to use various colorsinstead of grey scale.

As another option for evaluating bone density, the surgeon can useHounsfield unit conversion to compare scan slices of the patient's boneto each other 550 (FIG. 2).

Using the software application, the surgeon can perform segmentationanalysis on the scan of the patient's bone to create scan slices. Again,the scan slices may have a thickness of 1 mm. Then, the softwareapplication can calculate the bone density of each scan slice usingHounsfield values. U.S. Pat. Pub. Nos. 2015/0119987 and 2015/0080717,hereby incorporated by reference in their entirety, disclose methods ofderiving bone density from scan data using Hounsfield values.

After, the software application can use an algorithm to assign each scanslice a color on the RGB color scale to indicate areas of higher, aboutthe same, or lower density as compared to each other. For example, greenslices are more dense than yellow slices which are more dense than redslices. It is also possible to use a gray scale instead of a RGB colorscale. Then, the colored scan slices may be combined to show bone volumeand the 3D color scheme may be applied to the corrected bone model, asearlier discussed.

Visual information showing relative bone densities can be very useful toa surgeon when he is deciding which areas of the bone can provide forproper alignment and fixation of a bone plate. In the preferredembodiment, the surgeon can use color filtration options to show onlyrelatively high, moderate, or low density bone areas. This is especiallyuseful for patients with osteoporosis. Accordingly, the surgeon canensure that fixation holes in a bone plate correspond to bone areas withrelatively high or moderate density. It is not usually recommended todrill into areas of bone with relatively low density.

For the next step of pre-operative plan 80, the surgeon can customizethe bone plate 600 (FIG. 2). For example, the surgeon may customize thenumber and location of fixation holes in the bone plate to correspond toareas of bone with relatively high or moderate density.

To do so, the surgeon can use the software application to project aplate template over the corrected bone model. The plate template may bea Talus Navicular Cuneiform and Metatarsal (TNCM) plate, a NavicularCuneiform and Metatarsal (NCM) plate, a Cuneiform and Metatarsal (CM)plate. These templates correspond to standard sized bone plates used forCharcot, midfoot, flat feet, cavus foot, and related indications ordeformities. As an example, FIG. 13 shows a profile 610 of a TNCM platetemplate projected over the corrected bone model. When the surgeon isentering treatment information 100, the surgeon has the option to choosewhich plate type may be used 611 (FIG. 3). The surgeon can change platetypes as desired in the options menu 612 (FIG. 13).

Thereafter, the surgeon can select a type and length of fixation element60. For example, a 3.5 mm VariAx screw may be used for procedures in theforefoot and midfoot. Then, the software application may illustrate thetrajectory of fixation element 60 through the bone volume, as shown inFIG. 14. At this point, the surgeon can adjust the orientation offixation element 60 and make other modifications.

In certain cases, it may be desirable to use fixation elements ofdifferent types or lengths. For example, a surgeon may choose to usemono-axial screws for lower density bone areas and poly-axial screws forhigher density bone areas.

By default, the software application may show the minimum number offixation holes 30 for the selected plate template. That is, the softwareapplication will pre-determine the minimum size of a fixation hole 30such that a fixation element can pivot during actuation relative to therotation of the second bone portion 12 about axis R. Then, the surgeoncan easily add or delete a fixation hole 30, or change the location of afixation hole 30 by clicking or dragging the cursor. However, it isrecommended that profile 610 of the bone plate provide sufficientclearance given the number and location of fixation holes 30.

To ensure sufficient clearance, the software application may enforceboundaries 620, i.e. minimum and maximum plate dimensions, based on thenumber and location of fixation holes 30. As shown in FIG. 15,boundaries 620 can be set based on a calculated maximum distanceA,B,C,D,E, and F between each pair of fixation holes 30. Accordingly,the surgeon may not move a fixation hole (30) beyond boundaries 620(FIG. 16).

To move a fixation hole 30 within boundaries 620, the surgeon canproject a 2D sketch plane 630 showing profile 610 of the bone plate.Alternatively, the surgeon may pick three anatomic landmarks on thecorrected bone model to place 2D sketch plane 630. It is beneficial touse a 2D sketch plane instead of a 3D sketch plane because it requiresmuch less data processing and computing power.

In 2D sketch plane 630, the surgeon can project profile 610 of the boneplate over the corrected bone model, as shown in FIG. 17a . By default,profile 610 of the bone plate may automatically align with sketch axis635. An enlarged view of 2D sketch plane 630 is shown in FIG. 17 b.

To facilitate the design process, the software application can showcircles 640 with short dashes and circles 650 with long dashes aroundeach fixation hole 30. Circles 640 can help show the minimum dimensionsof the plate. As such, circles 640 for adjacent fixation holes 30 caneither be tangent to each other or not touching each other (FIG. 18). Tothe contrary, circles 650 can help show the maximum dimensions of theplate. Circles 650 for adjacent fixation holes 30 can either be tangentto each other or overlapping each other (FIG. 19).

The dashed circles can be helpful because they can provide real-timevisual feedback to the surgeon as he defines the number and location offixation holes (30) within boundaries 620. In the software application,the surgeon can decide whether the dashed circles are visible sometimes,all the time, or not at all.

FIG. 29 shows another embodiment of a 2D sketch plane 1630 showingprofile 610 of the bone plate. The 2D sketch plane 1630 includesreference markers 1635 surrounding the fixation holes 30 that can beused similar to boundaries 620. That is, each reference marker 1635 mayhave a predetermined tolerance range 1640 such that a fixation hole 30cannot be moved beyond the minimum and maximum plate dimensions (FIG.30).

As previously mentioned, it may be desirable to use fixation elements ofdifferent types or lengths and fixation holes of different sizes fordifferent applications. For example, a bone plate may have at least onerelatively large fixation hole adapted to receive a fixation element ata plurality of angles such that a fixation element could pivot duringinsertion. Accordingly, the size of the circles 640,650 or the tolerancerange 1640 may vary among fixation holes 30.

Once the number and location of fixations holes 30 are defined, profile610 of the bone plate may automatically regenerate. Now, the surgeon cantranslate, rotate, or otherwise manipulate profile 610 to better matchpatient bone anatomy. More particularly, profile 610 can be customizedto better match the anatomy of the first and second bone portions 11, 12in the corrected position in the 2D plane.

After profile 610 is defined in the 2D plane, the surgeon may also usethe software application to test its clearance in a 3D plane (FIG. 31).The software application may project a smaller proxy surface 1650 and alarger proxy surface 1660 over the profile 610 wherein the proxysurfaces 1650, 1660 correspond to the curvature of the corrected bonemodel. The smaller proxy surface 1650 may represent the maximumcurvature for clearance while the larger proxy surface 1660 mayrepresent the minimum curvature for clearance. Thus, the profile 610 maybe customized so that it is disposed between the proxy surfaces 1650,1660. This may help the bone plate 20 better match patient anatomy whenthe first and second bone portions 11, 12 are in the corrected position.For example, the surgeon can make sure that a portion of the profile 610a falls under proxy surface 1660; otherwise, portion 610 a may “stickout” creating a gap between the bone plate 20 and the bone due to poormatching.

The surgeon can also drag and manipulate surface contours of inferiorsurface 29 of the bone plate to bend the plate in a 3D plane, as shownin FIG. 20. This can also help the surgeon design the bone plate tobetter match the anatomy of the first and second bone portions 11, 12 inthe corrected position. Specifically, an inferior surface 29 a of thefirst section 21 of the bone plate may correspond well with an outersurface of the first bone portion 11, and an inferior surface 29 b ofthe second section 22 of the bone plate may correspond well with anouter surface of the second bone portion 12 (FIG. 14).

Furthermore, the surgeon can customize thickness T₁ of the bone plate.Thickness T₁ of the bone plate is defined by the linear distance betweenthe superior and inferior surfaces 27, 29 of the bone plate (FIG. 20).In some embodiments, the thickness T₁ of the bone plate may vary alongthe first and second sections 21,22 to better match patient anatomy.Still, it is important that the bone plate can be thick enough toprovide enough threads, or other fastening means, for proper alignmentand fixation.

If the thickness of the bone plate is minimized, the surgeon may wish toinclude a protrusion on the superior surface 27 of the bone platesurrounding a fixation hole 30 in order to facilitate insertion of afixation element. For example, a protrusion may create a support area toguide a fixation element into the fixation hole. A protrusion may alsoprovide additional threads, or other fastening means, for properalignment and fixation. When the surgeon is entering treatmentinformation 100, the surgeon has the option to add these types of designnotes 146 (FIG. 3).

Sometimes the surgeon may require a drill guide for proper placement ofthe bone plate. As shown in FIG. 21, drill guide 621 includes a superiorsurface 627 and an inferior surface 629 that may be pre-operativelyplanned to match the patient's anatomy. Drill guide 621 also has athickness T₂ defined as the linear distance between the superior andinferior surfaces 627, 629 of the drill guide 621.

Additionally, drill guide 621 has drill holes 630 adapted to receive adrilling tool. The location and orientation of drill holes 630correspond to the location and orientation of fixation holes 30 on thebone plate 20. Thus, the angle of a drill hole 630 corresponds to thetrajectory of the fixation element upon insertion. The softwareapplication can compute specific drill hole angle values based on thedesired length of fixation elements in order to create a complementarydrill guide. During computation of the drill hole angle values, thesoftware application can also avoid interference between fixationelements and nerves. Thus, the resulting drill guide can be used todirect insertion of fixation elements at a pre-specified drill holeangle. When the surgeon is entering treatment information 100, thesurgeon has the option to indicate a need for a drill guide 621 (FIG.3). Thus, the software application can create a complementary drillguide according to the corrected bone model 620 (FIG. 2).

As a final step of pre-operative plan 80, the surgeon may review andapprove a complete design for the patient-specific plating system 700(FIG. 2). In the preferred embodiment, this may include simulating anoperative technique on the corrected bone model. Moreover, in someembodiments, the simulation may be performed in the operating room suchthat any necessary patient-specific modifications can be madeintraoperatively using, for example, additive manufacturing.

At the start of the simulation, first and second bone portions 11,12 arein a deformed position with respect to each other. Then, the surgeon cancalculate apex point 310 of the deformity and optionally perform anosteotomy to remove bone cut out 802. As shown in FIG. 22, the firstbone portion 11 is above apex point 310 and the second bone portion 12is below apex point 310.

Next, the surgeon can simulate positioning the customized bone plate 20such that the inferior surface 29 a of the first section 21 of the boneplate contacts the outer surface of first bone portion 11, and thesecond section 22 of the bone plate extends below apex point 310. Asshown in FIG. 23, the surgeon may secure the first section 21 of thebone plate to the first bone portion 11 in the simulation. To do so, thesurgeon could insert a first fixation element 60 a through a firstfixation hole 30 a in the first section 21 of the bone plate, and intothe first bone portion 11.

The surgeon may use additional fixation elements 60 to secure the firstsection 21 of the bone plate to the first bone portion 11. Heads 61 a ofthe fixation elements in the first section 21 of the bone plate may bealmost flush with the superior surface 27 of the bone plate.

Moreover, the surgeon can simulate inserting a second fixation element60 b through a second fixation hole 30 b in the second section 22 of thebone plate, and into at least a part of the second bone portion 12 (FIG.23). In many applications, the second fixation element 60 b might belonger than the first fixation element 60 a. Also, the second fixationhole 30 b might be larger than the first fixation hole 30 a. A large orelongated fixation hole may be desirable because it allows the fixationelement to pivot during insertion.

Simulated actuation of the second fixation element 60 b may cause thesecond bone portion 12 to rotate along the axis of rotation R fordistance Θ such that first and second bone portions 11, 12 are in thecorrected position with respect to each other. In the correctedposition, the inferior surface 29 b of the second section 22 of the boneplate contacts the outer surface of the second bone portion 12 (FIG.24).

Once in the corrected position, the surgeon may use additional fixationelements 60 to secure the first and second sections 21,22 of the boneplate to the first and second bone portions 11,12. By the end of thesimulation, heads 61 of all fixation elements may be flush with thesuperior surface 27 of the bone plate.

As shown in FIG. 24, the deformity correction created gap 803 betweenthe first and second bone portions 11, 12 in the corrected position. Gap803 is sized to receive bone graft 442, as previously discussed.

At this point, the surgeon can evaluate the customized details of thebone plate and make any desired changes to the patient-specific platingsystem before manufacturing. More particularly, the surgeon may alterthe number or location of fixation holes, the orientation of fixationholes/elements, the type or length of fixation elements, the profile ofthe bone plate, the superior and inferior surfaces of the bone plate,the thickness of the bone plate, and/or any surface protrusions on theplate. For example, it may be particularly important for fixation hole30 b to be of sufficient size to allow the second fixation element 60 bto pivot during actuation, as the first and second bone portions 11, 12are arranged in the corrected position. The surgeon may also modifyrequests for a cut guide, a bone graft, and/or a drill guide.

Once the complete design for the patient-specific plating system isapproved, a file including the design can be exported for manufacturing.Generally, the time between initiating a case request 100 and approval700 may be approximately four working days (FIG. 2).

It is important to note that some steps of pre-operative plan 80 may beperformed by a third party instead of the surgeon. For example, aStryker design representative may perform the deformity assessment300,350; deformity correction 400; bone density evaluation 500, 550; andplate customization 600 (FIG. 2). If a third party is involved, it isrecommended that the surgeon pay careful attention to the design notes146 when entering treatment information 100 (FIG. 3). It is alsorecommended that the surgeon carefully review and approve the completedesign of the patient-specific plating system 700. In many cases, theremay be correspondence between the surgeon and the third party regardingmodifications to the customized bone plate before the system isapproved.

Customized bone plate 20 of FIG. 1 can be created using a computernumerical control (“CNC”) milling type operation or additivemanufacturing. Body 23 of the bone plate can be made of a biocompatiblematerial such as titanium or stainless steel.

The time for manufacturing may be approximately eight working days.Thus, the total time to create a patient-specific plating system wouldbe, for example, approximately twelve working days.

Overall, a patient-specific plating system according to the presentinvention may provide better patient matching as a result of in-depthpre-operative planning. Also, the creation and use of a customized boneplate may offer significant improvements over standard bone plates.

Notably, the deformity assessment and correction tools described hereinallow a surgeon to design a customized bone plate that can correctspecial situations or complex anatomy. With these tools, the surgeon canvisualize both a deformed bone model and a corrected bone model. Thismay be useful when correcting Charcot, midfoot, and ankle deformities,as well as other types of bone deformity in other parts of the body.

Furthermore, the customization of a profile and inferior surface of abone plate according to a corrected bone model can reduce pain anddiscomfort for the patient. This is because the profile and inferiorsurface of the plate may closely match the patient anatomy,particularly, the outer surfaces of the first and second bone portionsin a corrected position.

Using a software application, the surgeon can also visualize relativebone densities. This allows the surgeon to customize the number andlocation of fixation holes in a bone plate such that the bone plate canbe secured to higher density bone areas. This can promote healingbecause first and second bone portions can be properly aligned andsecured in the corrected position.

Moreover, the software application can enforce predetermined boundariesto ensure proper dimensions of the bone plate given the number andlocation of fixation holes. This prevents the bone plate being too smallor too large for a specific patient.

During pre-operative planning, the surgeon may also request: acomplementary cut guide which may improve the accuracy of bone-cuts inan osteotomy procedure; a complementary bone graft assessment which canfill a gap between first and second bone portions in a correctedposition; and a complementary drill guide which may facilitate platefixation. The complementary cut guide may be especially useful becausethe inferior surface may be preoperatively planned to better match thepatient's anatomy in order to help ensure proper placement of the cutguide. Thus, the surgeon may be able to make more accurate bone cuts, aswell as multi-angle bone cuts when using a single cut guide.

In addition, the customized bone plate is desirable to surgeons becauseit is quickly realizable (in about two weeks) and easy to manufacture.After manufacturing, the customized bone plate may be included as partof a surgical kit for the surgeon. The surgical kit may further includeat least two fixation elements, a cut guide, a bone knife, a drillguide, a drill, and/or a screw driver.

The method of using the patient specific plating system is alsoadvantageous because the surgeon can gradually rotate the second boneportion into a corrected position with better precision, compared toexisting methods. Although the method was described in reference to bonedeformities in the foot, the same method could be applied to correctother deformities in other parts of the body.

The following paragraphs will now describe the selection and use of aprefabricated or standard bone plate. It may be desirable to use aprefabricated bone plate, rather than a semi- or fully-customized boneplate, in order to reduce the time and expense associated with thesurgery. In many applications, a prefabricated bone plate willsufficiently hold the first and second bone portions in the correctedposition for healing.

The selection process can involve detailed pre-operative planning Oneembodiment of a pre-operative plan 8000 is illustrated as a flowchart inFIG. 32. Similar to pre-operative plan 80 previously described, manysteps of pre-operative plan 8000 also use a software application.

First, a surgeon may generate a corrected bone model 1100, in order toidentify landmark locations on the corrected bone model 2100. (FIG. 32).It is recommended that the surgeon choose at least three landmarklocations 3300 on the bone model. As shown in FIG. 33, the surgeon hasidentified nine landmark locations 3300. Each landmark location 3300 ischosen to correspond to a desired fixation hole location 3310. Often, itwould be desirable for the landmark locations 3300 to correspond toareas of the first and second bone portions 11, 12 having higherrelative densities.

Then, the surgeon can use the software application to access a libraryof prefabricated bone plate designs 3100. (FIG. 32). The library canhold several hundreds of prefabricated plate designs having differentfixation hole location combinations. The software application can thenbe used to compare proximity of the landmark locations 3300 with thefixation hole locations 3310 on the various prefabricated plate designs4100. (FIG. 32). To do so, the software application may calculate theaverage distance between each landmark location 3300 and each fixationhole location 3310 for each of the prefabricated plate designs. Thelowest average distance would likely result in the best matchingprefabricated plate design 3320. This plate design 3320 can then beprojected onto the corrected bone model for 3D visualization andevaluation. (FIG. 34).

It is also possible for the software application to display a pluralityof plate designs 3320 a-c that have an average proximity within apredefined tolerance level that would be considered adequate forhealing. (FIG. 35). Then, the surgeon could visually compare those platedesigns and select the plate design with the best-fit.

Alternatively, the surgeon may only select three landmark locations. Insuch a case, it may be desirable for two of the landmark locations 3300a-b to be extreme proximal locations in the first bone portion and thethird landmark location 3300 c to be an extreme distal location in thesecond bone portion. (FIG. 36). These three landmarks 3300 could be“locked in” such that the software application will only display platedesigns having fixation holes matching those landmark locations. Thesoftware application would then display a cluster 3330 of other possiblefixation hole locations corresponding to the remaining possible platedesigns 4200. (FIG. 32). As shown in FIG. 36, the three landmarks 3300a, 3300 b, 3300 c appear as a single option and could be colored, forexample, in red; while six or more holes in between the extreme proximaland distal ends appear as a cluster of possible fixation hole locations.Here, each fixation hole location has three possible optionscorresponding to three possible plate designs. The options could beshown in grey scale or color-coded, for example, green options g for thegreen plate design; purple options p for the purple plate design; andorange options (not labeled) for the orange plate design. The softwareapplication may also provide an additional indicator for a suggestedfixation hole location.

Next, the surgeon may choose a fourth landmark location from the optionsin one of the clusters. (FIG. 37). In response, the software applicationcan automatically adjust the other possible fixation hole locations.Generally, the surgeon will continue selecting landmarks in order ofdecreasing significance until the best-fit plate is determined.

Depending on the patient anatomy, the available options may increase,decrease, or reposition as more landmarks are identified. For example,if the fourth landmark location is chosen at the suggested fixation holelocations; the first, second, and third landmarks may reposition ordisplay a new cluster of green, purple, and orange options. Desirably,it is possible for the surgeon to change the landmark locations and/orprioritize the landmarks in real time.

Ultimately, the surgeon can select the best matching plate design basedon the chosen landmark locations 3300. The plate design can then beevaluated for review and approval 6100 (FIG. 32). During evaluation, thesurgeon can use the software application to simulate the correctionprocedure, in order to verify and test that the prefabricated platedesign is adequate for healing, for example, within a predefinedconfidence interval.

Although the bone-contacting surface of the prefabricated plate wouldnot be pre-operatively planned for a specific patient, the fixation holelocation could still be optimized for the specific patient. Therefore,going through the selection process according to the embodimentdescribed above would likely reduce patient pain and discomfort and/orpromote healing.

The following paragraphs will now describe the creation and use of asemi-customized patient specific bone plate. A semi-customized boneplate may include some patient-specific features for better patientmatching, while keeping resource costs low. It may also allow for designof the bone plate from information derived from 2D patient images suchas X-rays as opposed to 3D bone models. The Stryker Orthopedics Modelingand Analytics system (“SOMA”) is a population-based design environmentfeaturing a large database of bone morphology, including size, shape,density, and inner and outer cortical boundaries, drawn from diversepopulations. SOMA can be used in a combination with information derivedfrom X-ray images of a particular patient in order to fill-in 3Dinformation that is not available from 2D X-ray images. In such cases,SOMA in combination with X-ray images can be used to design an implantsuch as a bone plate that has both patient-specific and standard contactsurfaces and fixation features.

In some applications, a prefabricated bone plate can be modified toprovide better matching between the inferior surface of the bone plateand the outer surface of each of the first and second bone portions whenthe first and second bone portions are in the corrected position. Insome cases, it may be beneficial to design a bone plate having bothpatient-specific and standard bone contact surfaces. Based oninformation that can be derived from patient images, there may be anability to design a patient-specific contact surface for a portion ofthe bone plate, while selecting standard bone plate configurationsand/or sizes for other portions of the bone plate. It designing a boneplate for the foot, it may be beneficial to include a polymer on aportion of the inferior surface of the bone plate, particularly at thetalus. This may be desirable to minimize resistance during fusion of thejoint. It also may be desirable to facilitate proper plate alignment andfixation.

Bone quality data may be derived from an image (or data relating to animage) of at least one joint. The image (or image data) can be obtainedin a variety of ways, including by performing any medical imaging methodknown in the art, or by obtaining the image data from a collectionand/or database. For example, the image data may be obtained byperforming a CT scan. Additional suitable imaging methods include MRI,Electrical Impedance Tomography (“EIT”), Dual-Energy X-rayAbsorptiometry (“DXA” or “DEXA”), X-ray, ultrasound, and nuclearimaging, for example. The image data may further comprise a combinationof one or more different kinds of image data, for instance a compositeimage data that comprises both CT and MRI image data, for example.

The image data obtained may correspond to either a single individual orto a population of individuals. For instance, the image data maycorrespond to a joint of the individual for whom the press-fit is beingoptimized in accordance with the method(s) described herein. In thiscase, the parameters of the bone resection are being determined on apatient-specific basis such that the parameters optimize the press-fitbetween the individual anatomy and the articular implant. On the otherhand, bone quality may be derived from data representative of apopulation, for instance a representative or average data correspondingto a particular population of individuals. The population may representa class or sub-class of individuals, for instance members of anage-range, a gender, a class of individuals who suffer from a particularjoint or knee ailment, any other suitable population that is relevant toarticular implants, or any combination thereof. The SOMA database may befurther used, for example, by normalizing a set of data relevant to thepatient of interest onto a phantom tissue model. In this way, image datataken from a population may be used to derive the relevant bone qualityand to optimize the engagement between the implant and the patient'sbone.

Once the image data of at least one joint is obtained, bone qualityinformation can be derived by a variety of methods for calculating orestimating bone properties from the imaging modalities previouslydescribed, including CT, X-ray, MRI, DEXA, etc. Such methods of derivingbone quality information are described in U.S. Pat. Pub. No.2015/0080717 titled “Patient Specific Bone Preparation for ConsistentEffective Feature Engagement,” the disclosure of which is herebyincorporated by reference herein in its entirety.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

The invention claimed is:
 1. A system for correcting a deformity infirst and second bone portions having a deformed position with respectto each other comprising: a cut guide having a first portion fixable tothe first bone portion and a second portion fixable to the second boneportion in the deformed position, the first and second portions beingconnected by a gear module having a pivot axis about which the first andsecond portions rotate to pivot the first and second bone portions aboutthe gear module from the deformed position to a corrected position, thecut guide further having at least one cutting slot for resecting a bonecut out from at least one of the first and second bone portions; and abone plate having a body including first and second sections andsuperior and inferior surfaces, the inferior surface having apreoperatively planned shape to match an outer surface of each of thefirst and second bone portions when the first and second bone portionsare in the corrected position different than the deformed position. 2.The system of claim 1, wherein the inferior surface of the first sectionis adapted to contact the outer surface of the first bone portion abovean apex point of the deformity and the inferior surface of the secondsection is adapted to contact the outer surface of the second boneportion below the apex point of the deformity when the first and secondbone portions are in the corrected position.
 3. The system of claim 1,wherein a thickness of the body defined by a linear distance between thesuperior and inferior surfaces varies from a first end adjacent thefirst section to a second end adjacent the second section.
 4. The systemof claim 1, wherein the bone plate defines at least one fixation hole ineach of the first and second sections of the body.
 5. The system ofclaim 4, wherein a location of each of the fixation holes ispreoperatively planned to face areas of the first and second boneportions having higher relative density.
 6. The system of claim 4,wherein one of the at least one fixation holes is adapted to receive afixation element at a plurality of angles.
 7. The system of claim 4,wherein one of the at least one fixation holes is larger than another ofthe at least one fixation holes such that a fixation element in the oneof the at least one fixation holes is able to change angles duringinsertion.
 8. The system of claim 4, further comprising: a firstfixation element insertable into a fixation hole in the first section ofthe bone plate and a second fixation element insertable into a fixationhole in the second section of the bone plate.
 9. The system of claim 8,wherein the first and second fixation elements are different lengths.10. A system for correcting a deformity in first and second boneportions having a deformed position with respect to each other, thesystem comprising: a cut guide fixable to each of the first and secondbone portions in the deformed position, the cut guide having a bonefacing surface, an opposite surface and a cutting slot having a firstportion with a first opening defined in the opposite surface and asecond portion with a second opening defined in the opposite surface,the first portion and second portion being angled inwardly toward oneanother from the opposite surface toward the bone contacting surface,the second opening extending at a non-zero angle relative to the firstopening such that a combination of the first and second openingsapproximately form a V-shape; and a bone plate having a body includingfirst and second sections and superior and inferior surfaces, theinferior surface having a preoperatively planned shape to match an outersurface of each of the first and second bone portions when the first andsecond bone portions are in a corrected position different than thedeformed position.
 11. The system of claim 10, wherein the first openingand the second opening intersect at an intersection point.
 12. Thesystem of claim 11, wherein the cutting slot has a lower portion and anupper portion, the lower portion being defined by the first and secondportions and the upper portion including a slot extending from theintersection point and away from the lower portion.
 13. The system ofclaim 10, wherein the bone facing surface of the first section isadapted to contact the outer surface of the first bone portion above anapex point of the deformity and the bone facing surface of the secondsection is adapted to contact the outer surface of the second boneportion below the apex point of the deformity when the first and secondbone portions are in the corrected position.
 14. The system of claim 10,wherein a thickness of the body defined by a linear distance between thesuperior and inferior surfaces varies from a first end adjacent thefirst section to a second end adjacent the second section.
 15. Thesystem of claim 10, wherein the bone plate defines at least one fixationhole in each of the first and second sections of the body.
 16. Thesystem of claim 15, wherein a location of each of the fixation holes ispreoperatively planned to face areas of the first and second boneportions having higher relative density.
 17. The system of claim 15,wherein one of the at least one fixation holes is adapted to receive afixation element at a plurality of angles.
 18. The system of claim 15,further comprising: a first fixation element insertable into a fixationhole in the first section of the bone plate and a second fixationelement insertable into a fixation hole in the second section of thebone plate.